FDA regulation of steam baths and hot tubs

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For those interested in how the FDA regulates steam baths and hot tubs that are intended to be used for medical purposes, these links may be helpful.

First, the Center for Devices and Radiological Health (CDRH) home page for "device advice," http://www.fda.gov/cdrh/devadvice/.

Next, the Code regulation of those medical devices that are considered Physical Medicine devices.

Look specifically to Subpart F--Physical Medicine Therapeutic Devices.

Sec. 890.5100 Immersion hydrobath.
(a) Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.
(b) Classification. Class II (performance standards).

Sec. 890.5250 Moist steam cabinet.
(a) Identification. A moist steam cabinet is a device intended for medical purposes that delivers a flow of heated, moisturized air to a patient in an enclosed unit. It is used to treat arthritis and fibrosis (a formation of fibrosis tissue) and to increase local blood flow.
(b) Classification. Class II (performance standards).

890.5950 Powered heating unit.
(a) Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 890.9.

But as noted in the previous post, the words "device intended for medical purposes" are critical.

The "Device Advice" page contains relevant links to whether and how to file a 510(k) premarket notification submission and a premarket approval submission.
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